The Pharmaceutical Journal
Vol 279 No 7465 p177
18 August 2007

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Products

Accessing SPCs
The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online

New medicines
• Soliris
Prescription Products
• Clipper
SPC changes
• Xolair
Discontinued products
• Limclair
• Zoton suspension

New medicines

Soliris

Composition: Eculizumab.

Presentation: Concentrate for solution for infusion.

Class: Terminal complement inhibitor.

Indications: Treatment of paroxysmal nocturnal haemoglobinuria.

Dosage: Initial five-week phase (600mg via 25–45 minute intravenous infusion weekly for four weeks, then 900mg for one week) followed by a maintenance phase (900mg every 12–16 days). Patients should be monitored for one hour following infusion. If an adverse event occurs during administration, infusion of Soliris can be slowed or stopped, but the total infusion time must not exceed two hours.

Contraindications: Hypersensitivity to murine proteins, unresolved Neisseria meningitidis infection, lack of current vaccination against Neisseria meningitidis infection and known or suspected hereditary complement deficiencies.

Precautions: All patients must be vaccinated against meningococcal infection at least two weeks before treatment with Soliris and revaccinated in accordance with relevant guidelines. Vaccination may not be sufficient to prevent meningococcal infection, and so consideration should be given to use of antibacterial agents (in line with official guidance).

Treatment should be administered with caution to patients with active systemic infections. Administration of Soliris may result in infusion reactions or immunogenicity and these could cause allergic or hypersensitivity reactions (including anaphylaxis). Patients treated with Soliris should be monitored for signs and symptoms of intravascular haemolysis, including abnormal serum lactate dehydrogenase levels. Patients who discontinue treatment should be monitored for at least eight weeks for serious haemolysis and other reactions.

The product contains sodium (5mmol per vial), which should be considered when treating patients who are on a controlled sodium diet. Soliris should only be given to pregnant women if clearly needed. Women of childbearing potential should use adequate contraception methods during treatment and for up to five months after treatment with Soliris.

Side effects: Very common (>1/10) urinary tract infection, nasopharyngitis, upper respiratory tract infection, dizziness, headache, nausea, diarrhoea, back pain, arthralgia, pyrexia, contusion. Common (>5/100) respiratory tract infection, herpes simplex, sinusitis, viral infection, gastroenteritis, insomnia, epistaxis, pharyngolaryngeal pain, cough, vomiting, abdominal pain, constipation, rash, pruritus, myalgia, pain in extremities, muscle cramp, influenza-like illness, fatigue.

Legal category: POM.

Net price: 1 x 300mg vial, £3,150.

Contact details: Alexion Pharma, 3000 Cathedral Hill, Guildford, Surrey GU2 7YB (tel 01483 246641).

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Prescription Products

Clipper
Clipper (beclometasone diproprionate) gastro-resistant prolonged-release tablets are now available from Trinity-Chiesi.
Net price: 30 x 5mg, £60
Legal category: POM

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SPC changes

Xolair
Warnings about allergic reactions (including anaphylaxis and anaphylactic shock) experienced by patients taking Xolair (omalizumab; Novartis) have been added to the product’s summary of product characteristics.

A section on Churg-Strauss syndrome and hypereosinophilic syndrome has also been added, as well as a warning that patients should not drive or operate machinery if they experience dizziness, fatigue, faintness or drowsiness.

Severe thrombocytopenia, allergic granulomatous vasculitis (ie, Churg-Strauss syndrome) and alopecia have been added as possible side effects.

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Discontinued products

Limclair
Durbin has discontinued 1 x 6 ampoule packs of Limclair (trisodium edetate) injection 1g/5ml. Further information on 020 8869 6555.

Zoton suspension
Wyeth is discontinuing Zoton Suspension (lansoprazole). The orodispersible presentation (Zoton FasTab) remains available. Further information is available on 01628 415330.

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